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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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Help | More About 21CFR
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER L--REGULATIONS UNDER CERTAIN OTHER ACTS ADMINISTERED BY THE FOOD AND DRUG ADMINISTRATION
 
PART 1271HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS
 

Subpart A--General Provisions
   § 1271.1 - What are the purpose and scope of this part?
   § 1271.3 - How does FDA define important terms in this part?
   § 1271.10 - Are my HCT/P's regulated solely under section 361 of the PHS Act and the regulations in this part, and if so what must I do?
   § 1271.15 - Are there any exceptions from the requirements of this part?
   § 1271.20 - If my HCT/P's do not meet the criteria in 1271.10, and I do not qualify for any of the exceptions in 1271.15, what regulations apply?

Subpart B--Procedures for Registration and Listing
   § 1271.21 - When do I register, submit an HCT/P list, and submit updates?
   § 1271.22 - How and where do I register and submit an HCT/P list?
   § 1271.25 - What information is required for establishment registration and HCT/P listing?
   § 1271.26 - When must I amend my establishment registration?
   § 1271.27 - Will FDA assign me a registration number?
   § 1271.37 - Will establishment registrations and HCT/P listings be available for inspection, and how do I request information on registrations and listings?

Subpart C--Donor Eligibility
   § 1271.45 - What requirements does this subpart contain?
   § 1271.47 - What procedures must I establish and maintain?
   § 1271.50 - How do I determine whether a donor is eligible?
   § 1271.55 - What records must accompany an HCT/P after the donor-eligibility determination is complete; and what records must I retain?
   § 1271.60 - What quarantine and other requirements apply before the donor-eligibility determination is complete?
   § 1271.65 - How do I store an HCT/P from a donor determined to be ineligible, and what uses of the HCT/P are not prohibited?
   § 1271.75 - How do I screen a donor?
   § 1271.80 - What are the general requirements for donor testing?
   § 1271.85 - What donor testing is required for different types of cells and tissues?
   § 1271.90 - Are there exceptions from the requirement of determining donor eligibility, and what labeling requirements apply?

Subpart D--Current Good Tissue Practice
   § 1271.145 - Prevention of the introduction, transmission, or spread of communicable diseases.
   § 1271.150 - Current good tissue practice requirements.
   § 1271.155 - Exemptions and alternatives.
   § 1271.160 - Establishment and maintenance of a quality program.
   § 1271.170 - Personnel.
   § 1271.180 - Procedures.
   § 1271.190 - Facilities.
   § 1271.195 - Environmental control and monitoring.
   § 1271.200 - Equipment.
   § 1271.210 - Supplies and reagents.
   § 1271.215 - Recovery.
   § 1271.220 - Processing and process controls.
   § 1271.225 - Process changes.
   § 1271.230 - Process validation.
   § 1271.250 - Labeling controls.
   § 1271.260 - Storage.
   § 1271.265 - Receipt, predistribution shipment, and distribution of an HCT/P.
   § 1271.270 - Records.
   § 1271.290 - Tracking.
   § 1271.320 - Complaint file.

Subpart E--Additional Requirements for Establishments Described in 1271.10
   § 1271.330 - Applicability.
   § 1271.350 - Reporting.
   § 1271.370 - Labeling.

Subpart F--Inspection and Enforcement of Establishments Described in 1271.10
   § 1271.390 - Applicability.
   § 1271.400 - Inspections.
   § 1271.420 - HCT/Ps offered for import.
   § 1271.440 - Orders of retention, recall, destruction, and cessation of manufacturing.

Authority: 42 U.S.C. 216, 243, 263a, 264, 271.
Source: 66 FR 5466, Jan. 19, 2001, unless otherwise noted.

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